Study Lifecycle Monitor Biostatistics Operations

Operational health of studies from protocol to CSR — deliverables, data readiness, TLF production, milestones.

SIMULATED DEMO DATA

Portfolio health RAG by dimension — click a cell to drill in

On track Watch At risk Dimensions: Timeline · Data · TLF · Resource
How the operational risk score works (transparent, no black box) Each dimension is a plain weighted 0–100 score, scaled by how close the relevant gate is: Timeline = overdue milestones + days-to-DBL pressure · Data = open-query backlog + (1−clean%) + (1−SDV%), weighted by DBL proximity · TLF = (1−finalized/planned) weighted by reporting proximity · Resource = double-programming lag + open discrepancies. Green <33, Watch 33–66, At risk >66. No predictive model, no experimental method — just the numbers your CTMS/EDC/TLF tracker already hold.

Operational early-warning signals ranked

Portfolio trend 8 weeks · all studies — direction of travel

Milestone track

Data readiness

TLF production planned → final

Deliverables pipeline (selected study) done / total by phase

Study roster click a row for detail · click a header to sort